LawyersUSA

The American Association for Justice is urging the Food and Drug Administration to call off implementation of a proposed rule that the trial lawyers' group said would provide immunity to drug companies for failing to warn patients of potential drug hazards.

The change to the so-called "changes to be effected" rule would limit the ability of drug companies to unilaterally change warnings on drug labels, allowing changes only in certain circumstances.

Currently, companies can change labeling information – including warnings, contraindications and information about potential adverse reactions – without prior approval by the FDA when the drug company obtains new information about such potential hazards.

The new rule would permit such changes only where new information shows "evidence of a causal association" between the drug and the potential hazard.

In its comments on the proposed rule, AAJ officials said Congress intended for drug manufacturers to have a duty to warn the public about potential problems when they become aware of drug risks.

"This proposed FDA rule is a giant step backward for patient safety," said AAJ President Kathleen Flynn Peterson in a statement. "Not only will it keep patients in the dark about the safety of their prescriptions, but will also shield companies from being held accountable for their negligence."